Comments for internal quality assurance or notified body auditors. 3. Key Checklist Modules by Clause
Are all source code files, tools, and documentation uniquely identified? Is there a formal change control process in place? 6. Software Problem Resolution Process (Clause 9) Iec 62304 Checklist Xls
An IEC 62304 Checklist in Excel format is a tool used by medical device software developers to ensure compliance with the (and Amendment 1:2015) standard . It typically maps specific standard requirements to project activities and documentation, categorized by software safety classes (A, B, and C). Core Content for an IEC 62304 Checklist Comments for internal quality assurance or notified body
Link your XLS checklist items directly to your Software Requirements Specification (SRS), Architecture Documents, and Test Protocols. Regulatory bodies like the FDA and EU Notified Bodies heavily inspect this traceability. Is there a formal change control process in place
Use prefix-suffix formats (REQ-SW-001, TC-INT-001, RISK-042) recorded in your RTM—Excel works fine for this, but discipline is required.
Process for approving and implementing updates.